MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for PEAK 3.0MM FIXATION ROD CUTTER 274641000 manufactured by Depuy Spine Inc.
[178231616]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Reporter is a synthes employee. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[178231617]
It was reported on an unknown date, during surgery, the surgeon attempted to cut the overhang of a 3. 5mm rod insitu after final tightening was already performed on a c3 - c7 construct. The overhang was located at the c3 level. The tip of the rod cutter broke apart into the patient. The surgeon was able to locate and remove all broken pieces and continued with the surgery. Fragments generated is unknown. Surgical delay is unknown. There were no patient consequences. The procedure outcome is unknown. Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: unknown). This complaint involves one (1) device. This 1 of 1 report for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00505 |
| MDR Report Key | 9677974 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-16 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2011-07-26 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEAK 3.0MM FIXATION ROD CUTTER |
| Generic Name | INSTRUMENT, CUTTING, ORTHOPEDIC |
| Product Code | HTZ |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 274641000 |
| Catalog Number | 274641000 |
| Lot Number | KM646313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |